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Clinical Trials/EUCTR2016-002396-99-FR
EUCTR2016-002396-99-FR
Active, not recruiting
Phase 1

Safety, tolerability, and pharmacokinetics study of single and multiple subcutaneous doses of turoctocog alfa pegol in patients with haemophilia A - alleviate 1

ovo Nordisk A/S0 sites36 target enrollmentJune 27, 2017
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ovo Nordisk A/S
Enrollment
36
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 27, 2017
End Date
October 15, 2018
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Male, age above or equal to 18 years at the time of signing informed consent,(part A).
  • •2\. Male, age above or equal to 12 years at the time of signing informed consent,(part B).
  • •3\. Diagnosis of congenital haemophilia A based on medical records (FVIII activity \<1%).
  • •4\. History of more than 150 exposure days to any FVIII containing products.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 3
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 45
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\. Previous participation in this trial. Participation is defined as signed informed consent. (Patients who have completed part A are allowed to also participate in part B. If so, a separate informed consent covering part B must be signed.)
  • •2\. Immune compromised patients due to human immunodeficiency virus (HIV) infection (defined as viral load \=400\.000 copies/mL and/or cluster of differentiation 4\+ (CD4\+) lymphocyte count \=200/µL performed at screening or defined by medical records no older than 6 months)
  • •3\. Any history of FVIII inhibitors (defined by medical records within 8 years of randomisation)
  • •4\. Inhibitors to FVIII (\= 0\.6 Bethesda unit (BU)) at screening, measured by Nijmegen modified Bethesda method at central laboratory.

Outcomes

Primary Outcomes

Not specified

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